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Re: 21 CFR Part 11

From: David J Garbutt <d.garbutt>
Date: Mon, 07 May 2007 00:01:07 +0200

> Hello Steve,
>
> It seems like NONMEM jobs are not part 11 compliant, are they? Also, PK
> analyses are exploratory and cannot be predefined. The FDA asks for SAS files
> and NONMEM works with text files. This also makes Part 11 less related.
>
> Thank you,
> Pavel
>
> ----- Original Message -----
> From: Steve Chapel
> Date: Thursday, April 19, 2007 12:07 pm
> Subject: [NMusers] 21 CFR Part 11
> To: nmusers
>
>> > I'm looking for the document from the FDA called the "21 CFR
>> > Part 11,"
>> > which are the regulations for the handling of electronic records
>> > and
>> > signatures required by the FDA.
>
Hi,

I have been off-line for a while so I missed this interesting thread.

NONMEM jobs are not compliant in themselves, but can be run in a compliant
environment. As some one else already mentioned a product I will refer you
to my paper at the PhUSE 2005 conference. It mentions SAS but the
environment discussed in that paper covers SAS, S-plus (batch) and NONMEM.

The easiest place to get the paper is at lex Janssen's site :
http://www.lexjansen.com/phuse/2005/as/as09.pdf

Dave

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Received on Sun May 06 2007 - 18:01:07 EDT

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